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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985668
Other study ID # K-2023-0991
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 5, 2023
Est. completion date December 31, 2026

Study information

Verified date June 2023
Source Region Stockholm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months and older
Eligibility Inclusion Criteria, known defects: - Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay) - High likelihood of platelet function disorder (aberrant screening test with inheritance) - Family investigation for platelet disorder Exclusion Criteria, known defects:: - Antiplatelet or anticoagulant drugs - vWF:GPIb below 0.40 IU/mL - Hematocrit below 0.35 or above 0.50 - Other coagulation disorder Inclusion Criteria, suspected platelet function disorder: - Bleeding investigation at Karolinska University Hospital Exclusion Criteria, suspected platelet function disorder:: - Antiplatelet or anticoagulant drugs - vWF:GPIb below 0.40 IU/mL - Hematocrit below 0.35 or above 0.50 - Other coagulation disorder

Study Design


Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Region Stockholm Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Platelet count effect on platelet-thrombus formation on collagen surface Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count < 150 x 10^9 /L. At study inclusion
Other ddAVP effect on platelet-thrombus formation on collagen surface Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion). Immediately before and 1 hour after administration of ddAVP.
Other Thrombus formation on collagen/TF Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor. At study inclusion
Primary Platelet-thrombus formation on collagen surface Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited. At study inclusion
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